DE102017126426B3 - A method of making a distal sleeve for a catheter, a distal sleeve for a catheter, and a catheter having a distal sleeve - Google Patents

Abstract

The invention relates to a method for producing a distal sleeve (10) for a catheter (100), comprising at least the following steps: (a) providing a tubular element (20); (b) forming at least two recesses (30, 32, 34) on a sleeve edge portion (22) of the tubular member (20) and thereby forming at least two serrated projections (40, 48, 56) on the sleeve edge portion (22); (c) reshaping the at least two serrated protrusions (40, 48, 56) by reducing a spacing of respective distal protruding ends (42, 50, 58) of the at least two serrated protrusions (40, 48, 56) and forming at least two, through which at least two serrated protrusions (40, 48, 56) of limited passage openings (70, 72, 74); and (d) bonding the at least two serrated protrusions (40, 48, 56) at least at their respective distal protrusion ends (42, 50, 58) to form a common connection region (80). The invention also relates to a distal sleeve (10) for a catheter (100) and to a catheter (100) having a distal sleeve (10).

Description

The invention relates to a method for producing a distal sleeve for a catheter. Further aspects of the invention relate to a distal sleeve for a catheter and a catheter having a distal sleeve.

In the DE 196 34 866 A1 For example, a catheter for injection and / or application of a fluid comprising a catheter shaft having a distal end and a catheter tip and a plurality of hollow needles is described. The hollow needles are movable by means of an actuating device and can be pushed out on lateral needle exit openings arranged in the region of the distal end.

The US 2012/0016339 A1 describes a device with a catheter comprising a needle for intraoperative cardiac injection. An end region of the catheter can be bent in different directions by means of a plurality of guide wires arranged within the catheter. The guidewires are coupled to respective movement mechanisms that can be manually operated by an operator.

From the EP 2 337 605 B1 For example, a needle catheter is known which comprises a tension wire arranged within a catheter shaft of the catheter, by means of which a distal shaft area can be bent by applying a tensile force to the tension wire. For this purpose, the tension wire is connected to the distal shaft area.

The US 2007/0005018 A1 discloses a catheter with needles for direct injection. A distal end of the catheter is movable by an operator by means of a positioning device opposite the distal end.

Object of the present invention is to provide a method of the type mentioned, by means of which a distal sleeve for a catheter can be produced with particularly little effort. Another object of the invention is to provide a distal sleeve and a catheter with a distal sleeve.

These objects are achieved by a method having the features of patent claim 1, by a distal sleeve having the features of patent claim 8 and by a catheter having the features of patent claim 9. Advantageous embodiments of the invention are the subject of the dependent claims.

1. a) Bereitstellen eines rohrförmigen Elements;
2. b) Erzeugen wenigstens zweier Ausnehmungen an einem Hülsenrandbereich des rohrförmigen Elements und dadurch Ausbilden wenigstens zweier zackenförmiger Vorsprünge an dem Hülsenrandbereich;
3. c) Umformen der wenigstens zwei zackenförmigen Vorsprünge unter Verringerung eines Abstands jeweiliger distaler Vorsprungsenden der wenigstens zwei zackenförmigen Vorsprünge sowie unter Ausbildung wenigstens zweier, durch die wenigstens zwei zackenförmigen Vorsprünge begrenzter Durchgangsöffnungen; und
4. d) Verbinden der wenigstens zwei zackenförmigen Vorsprünge zumindest an deren jeweiligen distalen Vorsprungsenden unter Ausbildung eines gemeinsamen Verbindungsbereichs.

A first aspect of the invention relates to a method for producing a distal sleeve for a catheter, comprising at least the following steps:

1. a) providing a tubular element;
2. b) producing at least two recesses on a sleeve edge region of the tubular element and thereby forming at least two prong-shaped projections on the sleeve edge region;
3. c) reshaping the at least two serrated protrusions while reducing a spacing of respective distal protrusion ends of the at least two serrated protrusions and forming at least two through apertures delimited by the at least two serrated protrusions; and
4. d) connecting the at least two serrated projections at least at their respective distal projection ends to form a common connection region.

The method makes it possible to produce the distal sleeve as a one-part component from the tubular element, whereby overall a particularly low-effort production of the distal sleeve is provided.

The tubular element may be formed, for example, a hollow cylinder. The tubular element can be provided in step a), for example, as a tube blank of a hollow tube. Such a pipe blank can be provided with very little effort. In addition, the tubular element may be formed of a biocompatible material, for example of a biocompatible, metallic material.

The production of the at least two recesses in step b) can take place, for example, by a machining process, that is to say for example by milling. By means of such a machining process, only a slight, partially heating of a tubular element to be machined takes place, so that a reaching a, a material structure of the tubular member changing temperature can be omitted when creating the recesses.

Additionally or alternatively, however, it is also possible to use a high-energy beam method, for example in the form of cutting out of material by means of a laser beam, for producing the at least two recesses. Such a high-energy beam method can be used with particularly low tool wear, for example of a laser, and with the formation of particularly few material particles, for example metal chip.

The forming of the at least two serrated projections in step c) can be done individually. In general, during forming, the respective distal projection ends can be bent at least in regions in the direction of a central axis of the tubular element. This makes it particularly easy that the through holes are arranged eccentrically, ie at a respective distance to the central axis.

In a further advantageous embodiment of the method according to the invention, a shaping tool for the simultaneous forming of all serrated projections can be used. This shaping tool can be designed, for example, as a sleeve element with a tool dome. The tool dome may be formed as a hollow dome. In order to simultaneously reshape all prong-shaped projections, after the recesses have been produced according to step b), the tubular element can be introduced with the prong-shaped protrusions ahead into a tool interior, that is, for example, into a sleeve interior of the sleeve element. Upon reaching the tool dome, the serrated projections can be deflected at a dome inner contour of the tool dome in the direction of the central axis and thereby formed. A tool opening, for example in the form of an opening on a tool tip of the forming tool, can be provided on the tool dome, so that the respective, distal projecting ends for connection according to step d) are particularly easily accessible. For example, a high energy beam can be passed through the die opening to still connect the ends of the serrated protrusions of the tubular element to its inserted state into the forming tool thereby forming the distal sleeve. By the high energy beam, the ends of the serrated projections, for example, partially merged and thereby connected to form the common connection region.

However, when joining the ends of the serrated projections according to step d), an adhesive method can also be used, and accordingly the serrated projections are connected to one another by adhesive, for example by a suitable resin. Such an adhesive method can be used with a particularly low energy input.

In an advantageous development of the invention, at least the respective distal projection ends of the at least two tooth-shaped projections are contacted with each other during forming in step c). This is advantageous since, as a result, the subsequent connection of the serrated projections in step d) can take place with particularly little effort. Thus, for example, the use of any bridging elements for closing any gaps between the serrated projections on the connecting region can be dispensed with.

In a further advantageous development of the invention, the respective distal projection ends are connected to one another in a material-locking manner in step d). This is advantageous since, in this way, a reliable connection of the distal projection ends can be created even in a narrow space.

In a further advantageous embodiment of the invention, the respective distal projection ends are connected by their heating by means of a high energy beam or by resistance welding or by gluing or by soldering materially connected to each other. This is advantageous since a connection by means of high-energy beam, by resistance welding, by gluing or by soldering can be carried out with particularly little effort.

In a further advantageous development of the invention, a laser beam or an electron beam is used as the high-energy beam. This is advantageous since a laser beam or an electron beam can be used to create a particularly durable connection of the serrated projections on the distal projection ends with a particularly short time expenditure.

In a further advantageous embodiment of the invention, the at least two recesses in step b) are arranged uniformly on the sleeve edge region. This is advantageous since component stresses occurring during forming of the serrated projections can thereby be distributed particularly uniformly over the tubular element. A further advantage is that the passage openings thereby also distributed evenly and can be arranged, for example, eccentric to the central axis. As a result, during the intended use of the distal sleeve on the catheter, respective needles, for example hollow needles, which are passed through the passage openings, can be guided out of the respective passage openings at an equidistant distance from each other. This allows, for example, a particularly uniform distribution of liquid by means of the needles.

• e) Polieren zumindest der wenigstens zwei zackenförmigen Vorsprünge zumindest an dem Verbindungsbereich.

In a further advantageous embodiment of the invention, the further step is:

• e) polishing at least the at least two serrated projections at least at the connection region.

This is advantageous since, due to the polishing, a particularly small surface roughness can be created at least at the connection region.

A second aspect of the invention relates to a distal sleeve for a catheter, which is produced by a method according to the invention, wherein at least one of the at least two passage openings is designed for performing at least one catheter hollow needle. By means of the passage openings, a particularly targeted guiding of the catheter hollow needles is made possible.

A third aspect of the invention relates to a catheter having a distal sleeve according to the first aspect of the invention. Such a catheter can be produced with particularly little effort.

The statements relating to one of the aspects of the invention, in particular to individual features of this aspect, also apply analogously to the other aspects of the invention.

The invention also includes developments of the method according to the invention, which have features as they have already been described in connection with the developments of the motor vehicle according to the invention. For this reason, the corresponding developments of the method according to the invention are not described again here.

• 1 eine Schnittdarstellung eines rohrförmigen Elements;
• 2 eine weitere Schnittdarstellung des rohrförmigen Elements an welchem mehrere Ausnehmungen sowie mehrere zackenförmige Vorsprünge erzeugt sind;
• 3 eine Schnittdarstellung einer distalen Hülse, welche durch Umformen der zackenförmigen Vorsprünge des rohrförmigen Elements und Verbinden jeweiliger distaler Vorsprungsenden der zackenförmigen Vorsprünge an einem gemeinsamen Verbindungsbereich gebildet ist;
• 4 eine Draufsicht auf eine Hülsenspitze der distalen Hülse gemäß einer in 3 durch einen Pfeil verdeutlichten Ansichtsrichtung B;
• 5 eine Seitenansicht eines Teilbereichs eines Katheters, welcher die distale Hülse umfasst; und
• 6 eine schematische Darstellung einzelner Verfahrensschritte eines Verfahrens zur Herstellung der distalen Hülse.

In the following, embodiments of the invention are described. This shows:

• 1 a sectional view of a tubular element;
• 2 a further sectional view of the tubular element on which a plurality of recesses and a plurality of serrated projections are produced;
• 3 a sectional view of a distal sleeve, which is formed by forming the serrated projections of the tubular member and connecting respective distal projection ends of the serrated projections on a common connection region;
• 4 a plan view of a sleeve tip of the distal sleeve according to an in 3 by an arrow clarified view direction B;
• 5 a side view of a portion of a catheter, which includes the distal sleeve; and
• 6 a schematic representation of individual process steps of a method for producing the distal sleeve.

The exemplary embodiments explained below are preferred embodiments of the invention. In the exemplary embodiments, the described components of the embodiments each represent individual features of the invention, which are to be considered independently of one another, which each further develop the invention independently of one another and thus also individually or in a different combination than the one shown as part of the invention. Furthermore, the described embodiments can also be supplemented by further features of the invention already described.

In the figures, functionally identical elements are each provided with the same reference numerals.

6 schematically shows individual process steps of a method for producing a in 3 . 4 and 5 schematically illustrated distal sleeve 10 for a present only in 5 illustrated catheter 100 ,

In one process step a) a provision is made of a tubular element 20 which is present in 1 and 2 is shown in a respective sectional view.

In a subsequent process step b) there is a generation of present three recesses 30 . 32 . 34 at a sleeve edge area 22 of the tubular element 20 and thereby forming three serrated protrusions 40 . 48 . 56 at the sleeve edge area 22 , The recess 30 . 32 . 34 as well as the serrated projections 40 . 48 . 56 are particularly evident in 4 recognizable. The recesses 30 . 32 . 34 are doing evenly on the sleeve edge area 22 arranged and thus evenly distributed.

In a subsequent method step c), the serrated projections are reshaped 40 . 48 . 56 reducing a distance of respective distal projection ends 42 . 50 . 58 the serrated projections 40 . 48 . 56 and forming three, by the serrated protrusions 40 . 48 . 56 limited passage openings 70 . 72 . 74 , which are also particularly evident in 4 are recognizable. The distal projection ends 42 . 50 . 58 have present respective triangular swept protrusion tips.

To the tubular element 20 To transform, this can with its respective, serrated projections 40 . 48 . 56 ahead in the direction of an illustrated by an arrow insertion direction E in a tool interior 98 a shaping tool 92 be introduced as in 3 is shown. The forming tool 92 may be formed as a sleeve member and designed as a hollow dome, forming tool dome 94 exhibit. When inserting the tubular element 20 in the forming tool 92 become the respective serrated projections 40 . 48 . 56 in the area of the distal projection ends 42 . 50 . 58 through the tool dome 94 transformed and contacted each other. When forming the serrated projections 40 . 48 . 56 they slide on a dome inner contour of the tool dome 94 along. As a result, at least the distal projection ends 42 . 50 . 58 in the direction of a central axis M of the tubular element 20 or the distal sleeve 10 bent.

At a dome tip of the tool dome 94 is a centrally located, in the tool interior 98 opening tool opening 96 provided, which accordingly as a breakthrough on the tool dome 94 is trained.

In a subsequent process step d) a connection of the serrated projections takes place 40 . 48 . 56 at least at their respective distal projection ends 42 . 50 . 58 forming a common connection area 80 , The connection area 80 is over the tool opening 96 from an environment of the forming tool 92 accessible from, leaving the reshaped, and in the present case after reshaping in the area of the central axis M contacted with each other, distal projection ends 42 . 50 . 58 by means of a high-energy beam formed, for example, as a laser beam 90 can be heated and thereby materially connected to each other.

To a very low surface roughness at the connection area 80 At least the connection area can be achieved 80 in a subsequent process step e) be subjected to polishing.

5 shows the on the catheter 100 mounted, distal sleeve 10 , It can also be seen here that at least two of the passage openings 70 . 72 . 74 respective catheter hollow needles 60 . 62 are performed.

Claims (9)

A method of making a distal sheath (10) for a catheter (100) comprising at least the following steps: a) providing a tubular element (20); b) forming at least two recesses (30, 32, 34) on a sleeve edge region (22) of the tubular element (20) and thereby forming at least two serrated projections (40, 48, 56) on the sleeve edge region (22); c) reshaping the at least two serrated protrusions (40, 48, 56) by reducing a spacing of respective distal protruding ends (42, 50, 58) of the at least two serrated protrusions (40, 48, 56) and forming at least two, through which at least two serrated projections (40, 48, 56) of limited passage openings (70, 72, 74); and d) connecting the at least two serrated projections (40, 48, 56) at least at their respective distal projection ends (42, 50, 58) to form a common connection region (80). Method according to Claim 1 , characterized in that at least the respective distal projection ends (42, 50, 58) of the at least two serrated projections (40, 48, 56) are contacted with each other during forming in step c). Method according to Claim 1 or 2 , characterized in that the respective distal projection ends (42, 50, 58) are connected to one another in a material-locking manner in step d). Method according to Claim 3 , characterized in that the respective distal projection ends (42, 50, 58) by the heating thereof by means of a high energy beam (90) or by resistance welding or by gluing or by soldering materially connected to each other. Method according to Claim 4 , characterized in that a laser beam or an electron beam is used as the high-energy beam (90). Method according to one of the preceding claims, characterized in that the at least two recesses (30, 32, 34) in step b) are arranged uniformly on the sleeve edge region (22). Method according to one of the preceding claims, characterized by the further step: e) polishing at least the at least two serrated projections (40, 48, 56) at least at the connecting region (80). A distal sheath (10) for a catheter (100) made by a method according to any one of Claims 1 to 7 wherein at least one of the at least two passage openings (70, 72, 74) is designed for performing at least one catheter hollow needle (60, 62). Catheter (100) with a distal sleeve (10) after Claim 8 ,

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